MAUDE Adverse Event Report: EDWARDS LIFESCIENCES SAPIEN 3 TRANSCATHETER HEART VALVE; PROSTHESIS. MITRAL VALVE, PERCUTANEOUSLY DELIVERED

Model Number 9600TFX29A

Device Problems Fluid/Blood Leak (1250); Difficult to Open or Close (2921)

Patient Problem Heart Failure/Congestive Heart Failure (4446)

Event Date 09/14/2022

Event Type  Injury  

Event Description

Approximately 2 years and 10 months post-implantation of a 29mm sapien 3 valve in the mitral position, the device was explanted and replaced with a surgical valve.The reason for the valve explantation was due to severe stenosis and moderate mitral insufficiency with decreased leaflet excursion.Per medical records review, the patient's heart failure has worsened and there are issues with all the patient's valves, both native and prosthetic.Both the 29mm s3 valve in the mitral position and the patient's native aortic valve were explanted, and a 27mm edwards surgical valve 23mm edwards surgical valve were implanted in the mitral and aortic positions, respectively.The patient's condition also required an ascending aortoplasty and aortic root enlargement.There was no indication in these records that the failure of the 29mm s3 valve, was due to a mechanic factor, but was due to the progression of the patient's continuing rheumatic disease as they grow older, which had an impact on both the native aortic valve and mitral bioprosthetic valve resulting in then having to be explanted and replaced with surgical valve.

Manufacturer Narrative

The investigation is ongoing.The valve was not returned for examination.

Manufacturer Narrative

Update to h6; component code, type of investigation, investigation findings, investigation conclusion.The 29 sapien 3 valve was not returned for evaluation.Without the device returned for evaluation, visual inspection, functional testing, and dimensional analysis were unable to be completed.A device history record (dhr) review was performed and did not reveal any manufacturing non-conformances that would have contributed to the complaint event.A lot history review was performed and revealed no other complaints relating to the complaint code.The following instructions for use (ifu) were reviewed: commander delivery system with s3/s3u.Based on this review, no ifu/training deficiencies were identified.The complaint for stenosis was unable to be confirmed based on the medical record.However, the complaint for central regurgitation and leaflet motion restricted in patient were confirmed based on the medical report.A review of the dhr, lot history review, and complaint history review did not provide any indication that a manufacturing non-conformance contributed to the complaint event.A review of ifu/training materials revealed no deficiencies.During the manufacturing process, all sapien 3 valves are 100% visually inspected for defects and 100% tested for proper coaptation under physiological backpressure conditions prior to release for distribution.Therefore, it is highly unlikely that a manufacturing defect or device malfunction contributed to the event.It should be noted that the thv was implanted in the native mitral position in this case.The sapien 3 (s3) with the commander delivery system (ds) was indicated for the native aortic valve, surgical bioprosthetic aortic, or mitral valve replacement only at the time of original implantation.So, it was off-label for native mitral valve replacement.As reported, "approximately 2 years and 11 months after implantation of a 29mm s3 valve into the native mitral position due to poly valvar rheumatic disease, the tmvr valve now has severe stenosis and moderate mitral insufficiency and with decreased leaflet excursion".Additionally noted that the gradient was 26mmhg at the time of admission which indicates the possibility of stenosis.Per the instruction for use (ifu), valve stenosis is a potential risk associated with bioprosthetic heart valves.Per the valve academic research consortium (varc), valve stenosis can result from a number of factors, including pannus, calcification, support structure deformation (out-of-round configuration), trauma (cardia-pulmonary resuscitation, blunt chest trauma), endocarditis, prosthetic valve thrombosis, and native leaflet prolapse impeding prosthetic leaflet motion.Valve stenosis may result in symptoms such as shortness of breath and decreased exercise tolerance, which may be accompanied by an increased gradient across the valve.This could be due to early calcification of the leaflets, host tissue overgrowth, or in rare cases, a non-functioning leaflet.Calcification is a well-recognized failure mode of bioprosthetic valves.The mechanisms for bioprosthetic heart valve tissue calcification are not fully understood.Many factors can contribute to the onset and propagation of calcification including patient-related (e.G.Patient age, disease state, immune status, and other co-morbidities), pharmacological, and intrinsic properties of the valve itself.It was noted from the medical report that "patient had pre-existing co-morbidities, which includes progression of the rheumatic disease as they grow older".Rheumatic heart disease results then from the inflammation and scarring of heart valves caused by rheumatic fever.Although rheumatic disease can affect any heart valve, it most commonly affects the mitral valve which lies between the two chambers of the left side of the heart.The damage can cause valve stenosis, valve regurgitation, and/or damage to the heart muscle.The patient had rheumatic disease in progression, which could scar/damage the heart valve or leaflets, and lead to leaflet motion restricted in the patient resulting in further central regurgitation.In this case, available information suggests that patient factors (rheumatic disease) may have contributed to the complaint event.However, a conclusive root cause was unable to be determined at this time.Complaint histories for all reported events are reviewed against trending control limits monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.No corrective or preventative actions are required.

• Brand Name: SAPIEN 3 TRANSCATHETER HEART VALVE
• Type of Device: PROSTHESIS. MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 15586512
• MDR Text Key: 301558180
• Report Number: 2015691-2022-08510
• Device Sequence Number: 1
• Product Code: NPU
• UDI-Device Identifier: 00690103194364
• UDI-Public: (01)00690103194364(17)210730
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2021
• Device Model Number: 9600TFX29A
• Device Catalogue Number: 9600TFX29A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 12 YR
• Patient Sex: Male